Anchoring system

ABSTRACT

The present disclosure relates to an anchor assembly. The anchor assembly includes an anchor defining a cavity and an opening to the cavity and an insertion member including a body having a proximal end portion and a flat distal end portion, and a head coupled to the proximal end portion of the body. The insertion member is configured for arrangement within the anchor cavity. A method of tissue repair and other anchor assemblies are also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/013,342, filed Dec. 13, 2007, the disclosure of which is incorporatedherein by reference in its entirety.

BACKGROUND

1. Field of Technology

The present disclosure relates to tissue repair, and more specifically,to an anchoring system for securing tissue to bone.

2. Related Art

Arthroscopic procedures often require soft tissue to be reattached tobone. To achieve this, anchors are placed in the bone and suturesattached to the anchor are passed through the tissue to securely retainthe tissue in place. When making a repair of soft tissue to bone, it isadvantageous to have as large an area of contact between the bone andtissue as possible. Anchor points spaced from one another in rows resultin a repair having a broader area of contact. A procedure, andcomponents for use in such procedure, that securely attaches tissue tobone using a plurality of attachment points over a large area of contactis needed. Such procedure must be able to be done in a quick andefficient manner with a minimum of recovery time for the patient.

SUMMARY

In one aspect, the present disclosure relates to an anchoring systemincluding an anchor having an internal bore, a plug disposed within theinternal bore of the anchor and wherein the plug has an internal cavity,and a locking member disposed within the internal cavity of the plug. Inan embodiment, the plug further includes a transverse hole. In anotherembodiment, the anchoring system further includes a flexible memberdisposed within the hole of the plug. In a yet another embodiment, theflexible member includes a suture. In a further embodiment, thetransverse hole includes a through hole. In yet a further embodiment,the flexible member is disposed within the through hole of the plug.

In an further embodiment, the internal bore of the anchor is configuredfor receiving a delivery device. In another embodiment, the anchorincludes a groove located on an inner wall of the anchor. In yet anotherembodiment, the plug is wedge-shaped. In a further embodiment, the plugincludes at least one tab. In yet a further embodiment, the tab isexpandable. In an embodiment, the plug includes at least two tabs, thetabs located on opposite sides of the plug. In another embodiment, thetwo tabs are expandable. In yet another embodiment, the internal cavityof the plug includes surface features. In a further embodiment, thesurface features include threads. In yet further embodiment, the anchorincludes surface features located on an outer surface of the anchor. Inan embodiment, the surface features include threads. In anotherembodiment, the locking member includes a head and a shaft coupled tothe head, wherein the shaft includes surface features configured forengagement with the surface features of the internal cavity of the plug.In yet another embodiment, the surface features of the shaft includethreads.

In another aspect, the present disclosure relates to a method of tissuerepair. The method includes inserting a first anchor into bone, whereinthe first anchor includes a flexible member coupled thereto; passingends of the flexible member through the tissue; inserting a secondanchor into the bone, the second anchor including an internal bore;providing a plug including an internal cavity and a transverse hole;passing at least one end of the flexible member into the hole of theplug; and inserting the plug into the internal bore of the secondanchor.

In an embodiment, the method further includes inserting a locking memberinto the internal cavity of the plug to secure the flexible memberwithin the internal bore of the second anchor and the tissue to thebone. In another embodiment, the method further includes tensioning theflexible member before placing the locking member within the plugcavity. In yet another embodiment, the plug includes at least one tab.The tab expands into a groove located on an inner wall of the secondanchor upon insertion of the locking member into the internal cavity ofthe plug. In a further embodiment, the transverse hole includes athrough hole. In yet a further embodiment, the method further includespassing the one end of the flexible member into the through hole. In anembodiment, the plug includes at least two tabs, the tabs located onopposite sides of the plug and wherein the tabs expand into the grooveupon insertion of the locking member into the internal cavity of theplug. In another embodiment, the method further includes removing thelocking member from the plug and tensioning the flexible member.

Further areas of applicability of the present disclosure will becomeapparent from the detailed description provided hereinafter. It shouldbe understood that the detailed description and specific examples, whileindicating the preferred embodiment of the disclosure, are intended forpurposes of illustration only and are not intended to limit the scope ofthe disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and form a part ofthe specification, illustrate the embodiments of the present disclosureand together with the written description serve to explain theprinciples, characteristics, and features of the disclosure. In thedrawings:

FIG. 1A shows a perspective view of the anchor of the presentdisclosure.

FIG. 1B shows a top view of the anchor of the present disclosure.

FIG. 2A shows an exploded view of the plug and locking member of thepresent disclosure.

FIG. 2B shows a side view of the plug and locking member of the presentdisclosure.

FIG. 3A shows perspective view of a delivery device having the anchor ofthe present disclosure disposed on a shaft of the delivery device.

FIG. 3B shows a side view of the anchor of the present disclosuredisposed on the shaft of the delivery device.

FIGS. 4A-4E show use of the anchoring system of the present disclosurein repairing tissue.

FIG. 5 shows a cross-sectional view of the anchoring system of thepresent disclosure.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The following description of the preferred embodiment(s) is merelyexemplary in nature and is in no way intended to limit the disclosure,its application, or uses,

FIGS. 1A and 1B show the anchor 10 of the present disclosure. The anchor10 includes an outer wall 11 having a proximal portion 11 a includingsurface features, such as threads, and a distal portion 11 b. The anchor10 also includes an internal bore 12 extending a length of the anchor10. A wall 13 of the bore 12 includes a proximal portion 14 and a distalportion 15. The proximal portion 14 includes a groove 16. The distalportion 15 includes a first surface 17 and a second surface 18. Thefirst surface 17 is flat and the second surface 18 is arc-shaped. Thedistal portion 15 is configured for receiving a delivery device and aplug, as further discussed below.

FIGS. 2A and 2B show the plug 20 and the locking member 30 of thepresent disclosure. The plug 20 is substantially wedge-shaped andincludes a proximal end 20 a and a flat distal end 20 b. An outer wall21 of the plug 20 includes a first surface 22 and a second surface 23.The first surface 22 is substantially flat and includes a slot 24. Thesecond surface 23 includes a proximal end 23 a and a distal end 23 b.The distal end 23 b is substantially arc-shaped and the proximal end 23a includes tabs 25 and a recessed portion 26 located between the tabs 25and the distal end 23 b. The recessed portion 26 allows the tabs 25 toexpand, as will be further described below. Although FIGS. 2A and 2Bshow two tabs 25, a higher or lesser number of tabs 25 may be present.The first and second surfaces 22,23 are configured to allow the surfaces22,23 to conform to the surfaces 17,18 of the plug distal portion 15,thereby allowing for easier receipt of the plug 20 into the internalbore 12 of the anchor 10, as will be further described below. The plug20 also includes an internal cavity 27 having surface features 28, suchas threads, and a transverse through hole 29. The cavity 27 extends intothe through hole 29.

The locking member 30 includes a head 31 and a shaft 32 coupled to thehead 31. The shaft 32 includes surface features 33, such as threads,configured for engagement with the threads 28 of the plug 20 when thelocking member 30 is disposed within the plug 20, as shown in FIG. 2B.

The anchor 10 of the present disclosure may be used in conjunction withanother anchor to repair soft tissue. FIGS. 3A and 3B show the anchor 10located on the shaft 41 of a delivery device 40 in preparation forinsertion of the anchor 10 into bone, as will be more fully describedbelow. The delivery device 40 includes the shaft 41 having a distalportion 41 a, configured for engagement with the internal bore 12 of theanchor 10, and a proximal portion 41 b coupled to a handle 42. As shownin FIG. 3B, the distal portion 41 a includes a pointed end 41 a ₁, afirst surface 41 a ₂, and a second surface 41 a ₃. The first and secondsurfaces 41 a ₂,41 a ₃ are configured to allow the surfaces 41 a ₂,41 a₃ to conform to the surfaces 17,18 of the internal bore 12, therebyallowing for easier receipt of the internal bore 12 onto the distalportion 41 a.

FIGS. 4A-4E show the anchoring system 50 in use during arthroscopicrepair of the rotator cuff. However, the anchoring system 50 may be usedin the repair of soft tissue in other parts of the body. FIG. 4A shows afirst anchor 60 that has been inserted into the lateral aspect of a bone70, such as a humeral bone. The anchor 60, which has a flexible member80, such as a suture, coupled thereto, is inserted into the bone 70, asoft tissue 90, such as a rotator cuff tendon, is placed on the bone 70to be located adjacent to the anchor 60, and the ends 81 of the flexiblemember 80 are placed through the soft tissue 90.

Next, the delivery device 40 is used to place a second anchor, such asthe anchor 10 of the present disclosure, into the medial aspect of thebone 70. The pointed end of 41 a ₁ of the shaft 41 is used as an awl tostart the hole 71, by tapping the handle 42 with a surgical mallet, orother axially oriented, advancement force. The delivery device 40 isaxially advanced into the hole 71 until the distal portion 11 b of theanchor 10 is no longer exposed, as shown in FIG. 4A. The delivery device40 is then rotated until the proximal portion 11 a of the anchor 10 isno longer exposed, as shown in FIG. 4B. The delivery device 40 allowsfor the creation of the hole 71 and insertion of the anchor 10 in onestep, rather than multiple steps. The delivery device 40 and anchor 10are shown in an enlarged view compared to FIGS. 4C-4E where the anchor10 is much smaller in size. The anchor 10 and delivery device 40 areshown in an enlarged view merely for the purposes of an increased levelof detail and for further understanding of the repair process.

Subsequent to the anchor 10 being placed in the bone 70, the deliverydevice 40 is removed, and at least one end 81 of the flexible member 80is passed through the transverse through hole 29 of the plug 20. Theplug 20 is then placed into the internal bore 12 of the anchor 10, asshown in FIG. 4C, such that the ends 81 extend out of the hole 71. Afterplacement of the plug 20 into the anchor 10, the ends 81 of the flexiblemember 80 may be pulled to provide a preferred amount of tension on theflexible member 80 and the soft tissue 90. This tension on the flexiblemember 60 can be seen in FIG. 4D, especially when comparing thesefigures to FIG. 4C. As shown in FIGS. 4D and 4E, after insertion of theplug 20 into the inner bore 12 of the anchor 10, the locking member 30is advanced into the internal cavity 27 of the plug 20, such that, aswill be further described below, the plug 20 expands to lock the plug 20within the inner bore 12 of the anchor 10. In addition, advancement ofthe locking member 30 secures the flexible member 80 within the throughhole 29 and the internal bore 12 and secures the tissue 90 to the bone70.

As shown in FIG. 5, advancement of the locking member 30 into the innerbore 12 causes the tabs 25 to expand outward 25 a and into the groove 16of the bore 12, thereby locking the plug 20 within the bore 12. Alsoshown is the impingement of the locking member 30 on the flexible member80, which secures the flexible member 80 within the through hole 29.Both the plug 20 and the locking member 30 are advanced via deliverytools that provide for axial and rotary advancement. The suture 80 mayneed to be retensioned subsequent to placing the locking member 30 intothe plug 20. If re-tensioning is necessary, the delivery tools may beused to remove the locking member 30, so that tension mat be applied tothe suture 80. The locking member 30 would then be re-inserted into theplug 20.

The anchor 10 and plug 20 of the present disclosure and the first anchor60 are made from a bioabsorbable polymer material via an injectionmolding process. However, other materials and processes may be used. Inaddition, the suture material is made from a bioabsorbable polymermaterial, but other material may be used. Also, the initial anchor, suchas the first anchor 40 shown above, may include more than one suture andthe sutures may be secured together at one attachment point, such aswithin the second anchor 10 shown above, or independently at more thanone attachment point. For the purposes of this disclosure, the lockingmember 30 is made from a biocompatible material, such as titanium,stainless steel, or polyetheretherketone (PEEK). However, the lockingmember 30 may be made from other absorbable or non-absorbable material.

Furthermore, the proximal portion 11 a of the anchor 10 may includefeatures other than threads to reduce the possibility of removal of theanchor 10 and the threads may extend the entire length of the anchor 10.Similarly, the outer wall 21 of the plug 20 and the internal bore 12 ofthe anchor 10 may include surface features other than those shown anddescribed to facilitate insertion and removal of the anchor 10 onto theshaft 41 and the plug 20 within the internal bore 12 of the anchor 10.In addition, the inner cavity 27 of the plug 20 and the shaft 31 of thelocking member 30 may include surface features other than threads 28,33for engagement of the locking member 30 with the plug 20. Also, for thepurposes of this disclosure, the location of the through hole 29 may beanywhere along the length of the plug 20. The shaft 41 of the deliverydevice 40 is made from a biocompatible material, such as stainlesssteel, and is coupled to the handle 42 by having the proximal portion 41b press-fit into a through hole 43 of the handle 42. However, othermaterials and methods of coupling may be used.

The anchoring system 50 of the present disclosure allows a surgeon toload a suture from a previously placed anchor and secure the suture inthe system 50 at a preferred tension. Furthermore, the system 50 allowsfor one or more sutures to be secured together at one attachment point,such as described above with the second anchor 10, or independently atseveral attachment points. This allows for a large area of contactbetween the tissue and the bone and results in a better repair.

As various modifications could be made to the exemplary embodiments, asdescribed above with reference to the corresponding illustrations,without departing from the scope of the disclosure, it is intended thatall matter contained in the foregoing description and shown in theaccompanying drawings shall be interpreted as illustrative rather thanlimiting. Thus, the breadth and scope of the present disclosure shouldnot be limited by any of the above-described exemplary embodiments, butshould be defined only in accordance with the following claims appendedhereto and their equivalents.

1-27. (canceled)
 28. A method of tissue repair comprising: inserting afirst anchor into bone, the first anchor having a flexible membercoupled thereto; passing ends of the flexible member through the tissue;inserting a second anchor into the bone, the second anchor including aninternal bore; providing a plug, the plug including a proximal end, aclosed distal end, an internal cavity, and a hole transverse to theinternal cavity; passing at least one end of the flexible member intothe hole of the plug; inserting the plug into the internal bore of thesecond anchor; and inserting a locking member into the internal cavityof the plug to secure the flexible member within the internal bore ofthe second anchor and the tissue to the bone.
 29. The method of claim 28further comprising tensioning the flexible member before placing thelocking member within the internal cavity of the plug.
 30. The method ofclaim 28 further comprising removing the locking member and tensioningthe flexible member.
 31. The method of claim 28 wherein the plugincludes at least one tab, wherein the tab expands into a groove locatedon an inner wall of the second anchor upon insertion of the lockingmember into the internal cavity of the plug.
 32. The method of claim 31wherein the plug includes at least two tabs, wherein the tabs expandinto the groove upon insertion of the locking member into the internalcavity of the plug.
 33. The method of claim 28 wherein the holecomprises a through hole.
 34. The method of claim 33 further comprisingpassing at least one end of the flexible member into the through hole ofthe plug.